Vygon IV Start Convenience Kits — Class II medical device recall Z-0933-2018
Terminated recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., reported 2018-03-21. The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting i
| Recall number | Z-0933-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., Dover, NH, United States |
| Recall initiated | 2017-10-03 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-01-06 |
| Quantity | 21,350 |
| Reason classes | potency, specification failure |
Product
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Reason for recall
The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0933-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.